Biogen Canada Inc. Release: Health Canada Approves PLEGRIDY (peginterferon beta-1a) For Adults With Relapsing Remitting Multiple Sclerosis

PLEGRIDY is the first and only pegylated interferon administered once every two weeks for the treatment of MS

MISSISSAUGA, ON, Aug. 13, 2015 /CNW/ - Today, Biogen Canada Inc. announces the Health Canada approval of PLEGRIDY^TM (peginterferon beta-1a), which has been approved for the treatment of adults with relapsing remitting multiple sclerosis (RRMS) to reduce the frequency of clinical exacerbations and to slow the progression of disability.¹ PLEGRIDY offers a unique combination of demonstrated efficacy, a favourable safety profile consistent with the established interferon class, and an every two week dosing schedule.¹

"PLEGRIDY is the first interferon dosed once every two weeks, which reduces the frequency of relapses and slows the progression of disability in people living with RRMS," said Dr. Marcelo Kremenchutzky, Director of the Multiple Sclerosis Clinic in London, Ontario. "PLEGRIDY provides the safety profile we have come to expect from an interferon, with demonstrated efficacy and the added convenience of a reduced dosing schedule."

Multiple Sclerosis (MS) is a chronic, often disabling disease that attacks the central nervous system (CNS), which is made up of the brain, spinal cord and optic nerves. Symptoms result, at least in part, from when a person's immune system attacks the protective covering, or myelin, of the brain and spinal cord and interferes with the transmission of nerve signals between the brain, spinal cord and other parts of the body.²

PLEGRIDY is a new molecular entity, resulting from the application of pegylation technology. Pegylation prolongs circulation time by: increasing molecular size resulting in a longer half-life, stabilizes the molecule by improving chemical stability and solubility for a longer shelf-life and shields from degradation and decreased immunogenicity.³ This allows patients to receive an interferon treatment with less frequent dosing. Beta interferons, like PLEGRIDY, are a commonly-used class of RRMS treatments which are thought to resemble the body's natural interferon that works with the immune system and helps regulate the body's immune response; however, the exact mechanism is not known.¹ It is thought that beta interferon can reduce (and might prevent) inflammation which can damage nerve fibres in MS.⁴

"We are pleased that Health Canada has been responsive in listing another disease-modifying therapy for those with multiple sclerosis," says Sylvia Leonard, National Vice President, Programs and Services, MS Society of Canada.  "This responsiveness means that Canadians with MS have a more diverse range of treatment options available to them to meet their needs and lifestyles. Individuals with MS who are interested in exploring treatment options are encouraged to consult with their healthcare team to find the course that is most appropriate for them."

Health Canada's approval is primarily based on Phase 3 data from the ADVANCE (105MS301) study³, one of the largest studies conducted with an interferon treatment in MS, which included 1,500 MS patients:

• Data from the first year showed that PLEGRIDY, dosed once every two weeks, significantly reduced annualized relapse rate (ARR) at one year by 36 per cent compared to placebo (p=0.0007).²
• A total of 1,257 patients treated with PLEGRIDY received at least one year, and 789 patients received at least two years of treatment.³
•  A total of 512 and 500 patients, received PLEGRIDY 125 micrograms every two weeks or every four weeks respectively during the placebo-controlled phase of the ADVANCE study (year 1).³

In year 2 of the ADVANCE study all patients received PLEGRIDY (placebo patients were randomized to PLEGRIDY every 2 weeks or every four weeks). The experience in year 2 was consistent with what was observed in year 1.¹

• In an analysis integrating interim data from the ADVANCE study and the extension study, ATTAIN (105MS302), a total of 1,468 patients received PLEGRIDY for up to 177 weeks (41 months) with an overall exposure equivalent to 1,932 person-years.¹
  • The experience in the ATTAIN study has been consistent with the experience in the 1-year placebo-controlled phase of the ADVANCE study.^1,3
• In the ADVANCE study, PLEGRIDY reduced the risk of 12-week confirmed disability progression, as measured by the Expanded Disability Status Scale (EDSS), by 38 per cent (p=0.0383), compared to placebo.³
• PLEGRIDY also significantly reduced the number of new or newly enlarging T2-hyperintense lesions compared to placebo (p=<0.0001).¹
• Over 2 years, the study also demonstrated low incidence (number of patients at risk) of immunogenicity (NAbs) against IFN (anti-IFN NAbs) (<1%).³

"Biogen is a leader in the research and development of MS therapies because we understand that MS impacts every person differently and that each individual has distinct treatment needs driven by the severity of their MS, the impact of disease symptoms, their preferred route of administration and their lifestyle," said Paul Petrelli, President and General Manager, Biogen Canada Inc. "The approval of PLEGRIDY gives Canadian neurologists a new option to help address the unique needs of their patients."

PLEGRIDY is already approved in the US and the EU. PLEGRIDY will be made available to Canadians in Q1 of 2016.

Multiple Sclerosis in Canada
Canada is known to have one of the highest prevalence of MS in the world.⁵ Currently, more than two million people are estimated to suffer with MS worldwide,⁶ including an estimated 100,000 Canadians.⁷ The result of damaged myelin from MS may be a wide variety of symptoms including fatigue, weakness, muscle spasms, pain, tremors, double vision, bladder and bowel dysfunction, cognitive deficits and loss of mobility, among other problems.⁸

About PLEGRIDY
PLEGRIDY is a subcutaneous injectable therapy for RRMS, in which interferon beta-1a is pegylated to extend its half-life and prolong its exposure in the body.¹ PLEGRIDY is a member of the interferon class of treatments for MS.¹ It is generally recommended that patients may titrate to initiate treatment with 63 micrograms at dose 1, increasing to 94 micrograms at dose 2, reaching the full dose of 125 micrograms by dose 3 and continuing with the full dose every two weeks thereafter.¹

The most commonly reported adverse events with PLEGRIDY^TM treatment were injection site erythema, influenza-like illness, pyrexia, headache, myalgia, chills, injection site pain, asthenia, injection site pruritus, and arthralgia.¹

Please refer to the PLEGRIDY Product Monograph for additional safety information and complete prescribing information available at www.biogen.ca.

About Biogen ONE Patient Services Program
Biogen Canada Inc. is committed to delivering best-in-class quality and services to care for MS patients. All PLEGRIDY patients have access to a Regional Support Nurse in their region that provides personalized support for patients and healthcare providers in all aspects of patient care, from treatment to reimbursement. This enables healthcare providers and patients the opportunity to work directly with one nurse per region across all Biogen Canada Inc. MS products, which is intended to enhance the quality and continuity of care that Biogen ONE can provide to patients. For more information about the Biogen ONE program, call 1-855-MSONE-00 or 1-855-676-6300.

About Biogen Canada Inc.
Biogen Canada Inc. is the Canadian affiliate of Biogen Inc. Through cutting-edge science and medicine, Biogen Inc. discovers, develops, manufactures and markets therapies for diseases with a focus on neurology, immunology and hemophilia. Founded in 1978, with a presence in Canada since 1998, it is the world's oldest independent biotechnology company. Patients worldwide benefit from its leading multiple sclerosis therapies and the company generates more than $5 billion in annual revenues. For press releases and additional information about the company, please visit www.biogen.ca.

Biogen Canada Inc. Safe Harbor
This press release contains forward-looking statements, including statements about the potential and therapeutic impact of PLEGRIDY. These forward-looking statements may be accompanied by such words as "anticipate," "believe," "could," "estimate," "expect," "forecast," "intend," "may," "plan," "potential," "project," "target," "will" and other words and terms of similar meaning. You should not place undue reliance on these statements. These statements involve risks and uncertainties that could cause actual results to differ materially from those reflected in such statements, including uncertainty of success in our commercialization of PLEGRIDY, which may be impacted by, among other things, slower than anticipated acceptance of PLEGRIDY by patients and the medical community, intense competition in the MS market, the effectiveness of our sales force and marketing efforts, problems with the manufacturing process for PLEGRIDY, the occurrence of adverse safety events, difficulties in obtaining, or changes in the availability of reimbursement for our products, our failure to obtain regulatory approvals in jurisdictions outside of Canada, including in the event other companies receive marketing approval of their treatments before approval of our treatments, our failure to protect our intellectual property and other proprietary rights, product liability claims and the other risks and uncertainties that are described in the Risk Factors section of our most recent annual or quarterly report and in other reports we have filed with the U.S. Securities and Exchange Commission (SEC). Any forward-looking statements speak only as of the date of this press release and we assume no obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise.

REFERENCES

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¹ PLEGRIDY Product Monograph. Biogen Canada Inc. August 2015.
² Multiple Sclerosis Society of Canada. What is MS? Accessed August 2015. http://mssociety.ca/en/information/ms_what.htm.
³ Calabresi PA et al. Peginterferon Beta-1a for relapsing-remitting multiple sclerosis (ADVANCE): a randomised, phase 3, double-blind study. The Lancet Neurology, Volume 13, Issue 7, 657-665.
⁴National Multiple Sclerosis Society (NMSS). Beta interferon and glatiramer acetate. Accessed August 11, 2015. Available at http://www.mssociety.org.uk/what-is-ms/treatments-and-therapies/licensed-disease-modifying-drugs/beta-interferon-and-glatiramer-acetate
⁵ "MS Experts estimate number of Canadians with MS is 55,000 to 75,000." Multiple Sclerosis Society of Canada. Accessed August 15, 2015, http://mssociety.ca/en/research/medmmo-prev-may_02.htm.
⁶Hans-Peter Hartung, "Impact of mobility impairment in multiple sclerosis 1 Healthcare professionals perspectives." European Neurological Review: 110.
⁷ About MS." Multiple Sclerosis Society of Canada. Accessed August 11, 2015, https://beta.mssociety.ca/about-ms.
⁸ "Managing MS Symptoms." Multiple Sclerosis Society of Canada, accessed January 6, 2014, http://mssociety.ca/en/information/symptoms.htm.

SOURCE Biogen Canada Inc.